Terminated Class I

USPlabs, LLC

Recall F-1373-2014 · Dallas, TX

Product

USPlabs OxyELITE Pro Super Thermo POWDER Plus Advanced Carnitine Transport System DIETARY SUPPLEMENT Net Wt. 4.6 oz (130 g) BLUE RASPBERRY Manufactured for USPlabs, LLC (Dallas, TX 75220)

Reason for recall

USPlabs, LLC received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling products containing Aegeline and associated with serious adverse health events, namely serious liver damage or acute liver failure.

Distribution

Worldwide distribution including the following Worldwide distribution including the following international countries: Ecuador, Russia, UAE, South America, Dominican Republic, Kuwait, Philippines, Indonesia, Egypt, Panama, China, and Argentina.

Quantity affected

71,499 units

Recall type

Voluntary: Firm initiated

Lot / code info

UPC #094922426376

Timeline

9 Nov 2013 initiated 15 Jan 2014 classified 22 Jan 2014 reported 13 Oct 2015 terminated

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